BackgroundAs part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.

In order to provide this information in the timeliest manner, we now post the following information in “real time,” as this action taken against a mammography facility has concluded:

Adverse Event: On November 8, 2013, this facility was notified by the American College of Radiology (ACR) that it must participate in an Additional Mammography Review (AMR) due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. The facility voluntarily ceased performing mammography. On January 14, 2014, the ACR notified the facility that the problems found in the mammograms evaluated during its AMR revealed serious deficiencies involving the quality of mammography.

Action Taken:Based on the serious image quality deficiencies noted during the AMR, the FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients (and their providers) of the mammography image quality problems at the facility.

Corrective Action:The facility replaced its mammography equipment and provided training to its technologist and interpreting physician. On March 13, 2014, the facility met the requirements of the ACR for its provisional reinstatement of accreditation. On April 30, 2014, the FDA notified the facility that it successfully completed the PPN process. Subsequent to passing a follow-up AMR conducted by the ACR, CMS Open MRI & Diagnostic Services was granted full accreditation on July 24, 2014.